# K121757: Healthmateforever

- Pathway: 510(k) (Traditional)
- Applicant: Healthmate International, LLC
- Decided: Nov 20, 2012 after 158 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940301 (1994). 6 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102598: HI-Dow-XP, Hi-Dow International, Inc. (2011) Summary page 1.

## Most influential descendants
- K141978: Maxpower Relief (2014), 10 descendants of its own
- K160115: Heat Pain Pro (2016), 8 descendants of its own
- K131290: IQ Technologies (2014), 8 descendants of its own
- K190783: Health Expert Electronic Stimulator (model: AST-300L) (2020), 6 descendants of its own
- K141260: Electronic Pulse Stimulator (2014), 5 descendants of its own

## Indications for use
TENS (Transcutaneous Electrical Nerve Stimulation) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Powered Muscle Stimulator) It is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

Source page: https://510kreport.com/device/K121757
Methodology: https://510kreport.com/methodology